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This study will assess the efficacy of HH-120 nasal spray in participants for the post-exposure prevention of SARS-CoV-2.
During this study, participants will receive HH-120 nasal spray treatment for 7 consecutive days, the efficacy and safety of HH-120 nasal spray will be assessed throughout the study period mainly based on the incidence of symptomatic SARS-CoV-2 infection and adverse events, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HH-120 group | Experimental | HH-120 Nasal Spray |
|
| Control group | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HH-120 Nasal Spray | Drug | HH-120 nasal spray 8 times per day for 7 consecutive days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of symptomatic SARS-CoV-2 infection | Incidence of participants with quantitative Real-Time polymerase chain reaction (qRT-PCR) confirmed SARS-CoV-2 infection and COVID-19 related symptom | Up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of SARS-CoV-2 infection | Up to 7 days | |
| The changes in SARS-CoV-2 viral nucleic acid load | Up to 7 days | |
| The change of viral load by qRT-PCR |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Ditan Hospital, Capital Medical University | Beijing | 100000 | China | |||
| Huashan Hospital of Fudan University |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Placebo |
| Drug |
Placebo 8 times per day for 7 consecutive days |
|
| Up to 7 days |
| Incidence and severity of adverse events | Up to 21 days |
| The incidence of symptomatic SARS-CoV-2 infection | Up to 3 days |
| The incidence of symptomatic SARS-CoV-2 infection | Up to 5 days |
| Time to onset of first COVID-19 related symptom | Up to 7 days |
| Proportion of participants who progress to moderate/severe/critical type of COVID-19 or death | Up to 21 days |
| The incidence of symptomatic SARS-CoV-2 infection in different subgroups | Up to 7 days |
| The incidence and titer of antidrug antibody (ADA) | Up to 21 days |
| Shanghai |
| 200000 |
| China |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |